A Pilot study comparing Hypofractionated Accelerated Radiotherapy (HART) Vs Conventional Fractionated Radiotherapy (CFRT) in Newly Diagnosed High Grade Glioma (HGG): A Randomised non-inferiority Trial
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1. Response rate as per RANO criteria at 3, 6, 9 months of treatment.
研究概览
简要总结
Patient will be fully explain about the trial in their own language about the disease he is suffering from and possible modalities of treatment in their own language. Then patient consent will be take by informing possible outcome and reactions from treatment. Consent will be taken in fully conscious state. Patient will have right to withdraw from trial at any point of time if they wish. Patient wont be able to take any economical benefit by enrolling in the trial. Patient will kept on close follow-up and after treatment. Privacy of patient won’t be affected during and after treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Histologically confirmed cases of high grade gliomas: Anaplastic Astrocytoma (Grade 3), Astrocytoma (grade 4), Glioblastoma (Grade 4)
- •Age ≥ 18 years
- •KPS ≥ 70
- •Adequate renal, hepatic and hematologic function
- •Patients willing to participate in the study.
排除标准
- •Pregnancy
- •Previous history of chemoradiation
- •Other primary, recurrent or metastatic disease
- •Patients with significant life-threatening co-morbidities
- •History of acute or chronic liver disease.
结局指标
主要结局
1. Response rate as per RANO criteria at 3, 6, 9 months of treatment.
时间窗: At 3,6,9 months
2. Progression Free survival (PFS) at 9 months
时间窗: At 3,6,9 months
3. Overall Survival (O.S.) between the 2 arms at 9 months
时间窗: At 3,6,9 months
4. Comparison of quality of life between two arms
时间窗: At 3,6,9 months
5. Recurrence patterns of the two arms
时间窗: At 3,6,9 months
次要结局
- Recurrence pattern in 2 arm(At 3,6,9 months)
研究者
Dr Dharmendra Kumar Sah
POSTGRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH